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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Catheter, Ureteral
510(k) Number K921839
Device Name ENTRAC URETERAL BALLOON DILATION CATHETERS
Applicant
AMERICAN MEDICAL SYSTEMS, INC.
11001 BREN RD. EAST
MINNETONKA,  MN  55343
Applicant Contact SUSAN TESMER
Correspondent
AMERICAN MEDICAL SYSTEMS, INC.
11001 BREN RD. EAST
MINNETONKA,  MN  55343
Correspondent Contact SUSAN TESMER
Regulation Number876.5470
Classification Product Code
EZN  
Date Received04/17/1992
Decision Date 10/28/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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